HeartSine Samaritan PAD 300P AED Defibrillator

Technical Overview 

The products described here meet the applicable European Medical Directive requirements. U.S. Federal law restricts this device to sale by or on the order of a licensed practitioner. Physical With Pad-Pak™ Inserted Size: 8.0 in x 7.25 in x 1.9 in (20cm x 18.4cm x 4.8cm) Weight: 2.4 lbs (1,1 kg) including Pad-Pak Battery Defibrillator Waveform: Self-Compensating Output Pulse Envelope Biphasic waveform. Optimized biphasic escalating waveform compensates energy, slope and envelope for patient impedance Energy Selection Adult: 1. Shock 150J 2. Shock 150J 3. Shock 200J Pediatric: 1. Shock 50J 2. Shock 50J 3. Shock 50J Charging Time New Battery: Typically 150J in <8 sec., 200J in < 12 sec. After 6 Discharges: Typically 150J in <8 sec., 200J in < 12 sec. Patient Analysis System Method: Evaluates patient’s ECG, signal quality, electrode contact integrity and patient impedance to determine if defibrillation is required Sensitivity/Specificity: Meets ISO 60601-2-4 and AAMI DF80:2003 Environmental Operating/Standby Temperature: 0°C to 50°C (+32°F to +122°F) Temporary Transportation Temperature: –10°C to 50°C (14°F to 122°F) for up to two days. Unit must be returned to standby/operating temperature for 24 hours before use. Relative Humidity: 5% to 95% (non-condensing) Water Resistance: IEC 60529/EN 60529 IP56 Altitude: 0 to 15,000 feet (0 – 4,575 meters) Shock: MIL STD 810F Method 516.5, Procedure I (40G’s) Vibration: MIL STD 810F Method 514.5+ Category 4 Truck Transportation – US Highways Category 7 Aircraft – Jet 737 & General Aviation (Exposure) EMC: EN 60601-1-2, Second Edition: 2002

Radiated Emissions: EN55011:1999+A2:2001 Electrostatic Discharge RF Immunity: EN61000-4-3:2001 80MHZ-2.5GHZ (10V/m) Magnetic Field Immunity: EN61000-4-8:2001 (3 A/m) Aircraft: RTCA/DO-160F: 1997, Section 21 (Category M) RTCA DO-227 Falling Height: 1 meter Event Documentation Type: Internal Memory Memory Capacity: 90 minutes of ECG (full disclosure) and event/ incident recording Playback Capabilities: Custom USB cable directly connected to PC and Saver™ EVO Windows-based data review software Materials Used PAD SAM300P: ABS, Santoprene. Printed circuit board with electronic components. PAD Cartridge: Battery: Lithium Manganese Dioxide Housing: ABS – Electrodes: Hydrogel, Silver, Aluminium and Polyester Pad-Pak — Electrode and Battery Cartridge Adult Pad-Pak (Pad-Pak-01) and Pediatric Pad-Pak (Pad-Pak-02) Shelf Life: 4 years from manufacture date Weight: 0.44 lbs (0.2kg) Size: 3.93 in x 5.24 in x .94 in (10cm x 13.3cm x 2.4cm) Battery Type: Lithium Manganese Dioxide (LiMnO2) Capacity: Meets ISO 60601-2-4 and AAMI DF80:2003 18V, 1.5 Amp Hrs Electrodes: HeartSine samaritan® disposable defibrillation pads are supplied as standard with each device Placement: Anterior-lateral (Adult); Anterior-posterior (Pediatric) Active Gel Area: 100cm2 Cable Length: 3.5 ft (1m)